Study identification

EU PAS number

EUPAS1000000663

Study ID

1000000663

Official title and acronym

DARWIN EU® - Drug utilisation study on antibiotics in the ‘Access’ category of the WHO AWaRe classification of antibiotics for evaluation and monitoring of use

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Finland
Germany
Netherlands
Spain

Study description

The WHO 2023 ‎AWaRe classification‎ (who.int) of antibiotics for evaluation and monitoring of use classifies 258 antibiotics into 3 categories (Access/Watch/Reserve) according to their impact on antimicrobial resistance.
The ‘Access’ category includes antibiotics that are recommended as first- or second-line treatments for a wide range of common infectious diseases.
These antibiotics are generally active against a broad spectrum of commonly encountered, susceptible pathogens and have a relatively lower risk of promoting antimicrobial resistance compared to agents in other categories.
The WHO emphasizes that ‘Access’ antibiotics should be widely available, affordable, and of assured quality across all healthcare settings to ensure equitable treatment, especially in low- and middle-income countries.
As of the 2023 update, the ‘Access’ group includes 84 antibiotics, such as amoxicillin and doxycycline, which are used to treat high-burden infections like pneumonia and urinary tract infections.(1, 2) Promoting the use of ‘Access’ antibiotics for appropriate indications is a key component of global antimicrobial stewardship strategies aimed at reducing the need for broader-spectrum agents and mitigating the spread of resistance.
The DARWIN EU®_ P1-C1-003 study focused on the Watch category but there is now interest in including also the other category (‘Access’) to characterise the use of most antibiotics, and increased focus on the indication for use.
This study will improve the understanding of the use of antibiotics in routine health care delivery, including indication, treatment duration and trends over time. The results will contribute to the EU efforts to monitor use of antibiotics as part of the global fight against antimicrobial resistance.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Marzyeh Amini

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable